UroGen Pharma Publishes Results of Phase 3b Study on ZUSDURI Feasibility in Home Setting

UroGen Pharma announced the publication of Phase 3b study results in Reviews in Urology, demonstrating the feasibility of administering ZUSDURI for intravesical solution in the home setting. The study found that trained home health professionals can safely and effectively administer ZUSDURI, with a 75% complete response rate at three months and no new safety concerns. The study assessed feasibility, safety, and early efficacy in patients with recurrent LG-IR-NMIBC.

UroGen Pharma Ltd. (Nasdaq: URGN) announced the publication of Phase 3b study results in Reviews in Urology, demonstrating the feasibility of administering ZUSDURI for intravesical solution in the home setting. The study found that trained home health professionals (HHPs) can safely and effectively administer ZUSDURI, with a 75% complete response rate at three months and no new safety concerns. The study assessed feasibility, safety, and early efficacy in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

The study, titled "Home Instillation of UGN-102 for Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer: A Single-Arm, Open-Label, Phase 3b Trial," involved eight patients who received ZUSDURI via urinary catheter once weekly for six weeks. The first dose was administered in the clinic, followed by five at-home instillations by HHPs. Investigators found no meaningful differences between home and office instillation for most patients. The safety profile was consistent with previous studies, with most adverse events being mild-to-moderate urinary symptoms.

David Morris, MD, lead investigator and practicing urologist at Urology Associates, PC, Nashville, TN, stated, "The ability to deliver this treatment safely and effectively at home has the potential to ease the burden on patients and reduce reliance on hospital or clinic resources. As physicians, we’re always looking for ways to provide effective care with greater comfort and convenience. These findings represent an important step in that direction."

Mark Schoenberg, MD, Chief Medical Officer at UroGen, commented, "This patient-centered approach to care reflects our commitment to redefining how urologic cancers are treated, offering patients access to effective and convenient treatment options. The ability to potentially administer ZUSDURI safely in the home represents a meaningful advancement for patients and caregivers alike, especially those who may face challenges traveling to frequent clinic visits."

The study's limitations include a small sample size of eight patients and the open-label, single-arm design. Despite these limitations, the results suggest that home instillation of ZUSDURI is a promising approach for treating LG-IR-NMIBC.

References:
[1] https://www.morningstar.com/news/globe-newswire/9500771/urogen-announces-publication-of-phase-3b-study-results-demonstrating-the-feasibility-of-home-instillation-of-zusduri-for-recurrent-low-grade-intermediate-risk-non-muscle-invasive-bladder-cancer-in-reviews-in-urology
[2] https://www.nasdaq.com/articles/urogen-pharma-publishes-phase-3b-study-data-showing-feasibility-home-instillation-zusduri